# FDA 483 - Amneal Oncology Private Limited - March 15, 2018

Source: https://www.keypedia.com/records/483/amneal-oncology-private-limited/e59103d2-a4e6-4d0a-972a-08e2facf41da

> FDA 483 for Amneal Oncology Private Limited on March 15, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Amneal Oncology Private Limited
- Inspection Date: 2018-03-15
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: Amneal Oncology Private Limited in Hyderabad, India, was cited for significant deficiencies in its drug manufacturing facility. Observations included a lack of written production and process controls, inadequate quality control unit authority over data integrity, unrecorded deviations from procedures, and insufficient investigations into unexplained discrepancies. These issues indicate a serious lack of control over critical manufacturing and quality processes for sterile injectable drug products.

## Related Documents

- [483 - 2018-03-15](https://www.keypedia.com/records/483/amneal-oncology-private-limited/46271746-50e0-4be7-9b0e-4bcb5c3d04f8)
- [483 - 2023-11-17](https://www.keypedia.com/records/483/amneal-oncology-private-limited/5014f0e6-2d8d-4241-810b-204ec8108fb7)

## Related Officers

- [Carrie A. Hughes](https://www.keypedia.com/people/carrie-a-hughes/099d1128-0ba9-4e7a-a0d2-8c10083811c9)
- [Consumer Safety Officer ](https://www.keypedia.com/people/anastasia-m-shields/a22b8d52-e3f9-4e61-aa3f-6f03ff2f59df)

Company: https://www.keypedia.com/companies/amneal-oncology-private-limited/f2a5c5fe-c103-4cda-9a5b-c7007f51b4f2

Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321